Study Evaluating the Benefit of Two Immunosuppressive Strategies on Renal Function

Chronic Kidney Disease Clinical Trial

Official title:

Prospective Multicenter Randomized Openlabel Study to Evaluate the Benefit on Renal Function at 12months Post-transplantation of Immunosuppressive Treatment With Withdrawal of Calcineurin Inhibitor at 3months and Combining Mycophenolate Sodium-Everolimus Versus Tacrolimus-Everolimus, in Patients With de Novo Kidney Transplant

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02334488
• Other study ID #: PROMéTé
• Status: Completed
• Phase: Phase 3
• Start date: December 11, 2014
• Est. completion date: July 3, 2020

Study information

• Verified date: January 2021
• Source: Poitiers University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Prospective, multicenter, randomized and open label study evaluating the benefit on renal function at 12 months post-transplantation, with an immunosuppression without calcineurin inhibitor at 3 months and combining mycophenolate sodium-Everolimus versus an immunosuppression combining Everolimus-Tacrolimus, in de novo renal transplant patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 329
• Est. completion date: July 3, 2020
• Est. primary completion date: May 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients receiving a first kidney transplant from a cadaveric or living donor

Exclusion Criteria:

• Double transplant

• Patient who has been treated with an immunosuppressive drug or study drug during the four weeks before administration of the first dose of Everolimus

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• Everolimus
Active Comparator
• Tacrolimus
Active Comparator
• Mycophenolate sodium
Experimental Arm

Locations

Country	Name	City	State
France	Amiens University Hospital	Amiens
France	Angers University Hospital	Angers
France	Brest University Hospital	Brest
France	Caen University Hospital	Caen
France	Clermont Ferrand University Hospital	Clermont Ferrand
France	Limoges University Hospital	Limoges
France	Georges Pompidou European Hospital	Paris
France	Necker Hospital	Paris
France	Poitiers University Hospital	Poitiers
France	Reims University Hospital	Reims
France	Rennes University Hospital	Rennes
France	Rouen University Hospital	Rouen
France	Strasbourg University Hospital	Strasbourg
France	Tours University Hospital	Tours

Sponsors (1)

Lead Sponsor	Collaborator
Poitiers University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Renal function as measured by estimated glomerular filtration rate GFR	GFR unit : mL / min / 1.73 m2	One year after inclusion